Chronic Heart DisorderRERC-4aNCT00981344
Wheeled Mobility in Everyday Life
A study testing Wheeled Mobility in Everyday Life:Effects of Wheelchair Type on Mobility Performance of Elders in Public Environments in people with Chronic Heart Disorder and Lung Disorder, run by Duke University at 2 sites in United States.
Trial summary
The project will examine how mobility performance in real life tasks and environments is impacted by the use of specific types of wheeled mobility devices (wheeled walker, manual wheelchair, power wheelchair/scooter). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Heart Disorder, Lung Disorder, Arthritis
- What is being tested?
- Wheeled Mobility in Everyday Life:Effects of Wheelchair Type on Mobility Performance of Elders in Public Environments
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Prescribed wheeled walker, manual wheelchair, power mobility device in last 3-12 months
- Have chronic heart (e.g., congestive heart failure) or lung disorder (e.g., chronic obstructive pulmonary disease), and/or arthritic disorder (e.g., osteoarthritis)
- Reports using wheeled walker, manual wheelchair, or power mobility device in the preceding 2 weeks
Who cannot join
- Reports missing one or more limbs and/or complete paralysis of one or more limbs
- Have a neurological, myopathic, or cognitive disorder
- Weight more than 300 lbs; height more than 74 inches
- Poorly controlled hypertension, unstable angina, a heart attack or heart surgery within the last 6 months.
- Reports any of the following: Does not have an active Drivers License, unable to walk across small room without human help, unable to propel w/ch across small room without human help (applies only to those already using a manual w/ch), needs moderate assistance from another person to transfer, unable to sit on side of bed independently, currently has shoulder pain with self care or with wheelchair use.
- Major surgery affecting abdominal, chest, spine, upper extremity in the last 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27703
Durham VA Hospital
Durham, North Carolina, 27705
About this study
Official title: Wheeled Mobility in Everyday Life: Effects of Wheelchair Type on Mobility Performance of Elders in Public Environments
The project will examine how mobility performance in real life tasks and environments is impacted by the use of specific types of wheeled mobility devices (wheeled walker, manual wheelchair, power wheelchair/scooter). Specifically, the project will: 1) randomly recruit persons who were prescribed a mobility aid within the preceding 1 year and currently use the mobility aid, 2) define key mobility tasks within a public environment, 3) measure mobility performance of subjects as they perform the mobility tasks in each of the four devices, and 4) synthesize and disseminate the results. Study results will be used to establish baseline performance data for researchers and clinicians and to identify design improvements for wheelchairs used by community dwelling elders.
All study participants will be required to complete study related questionnaires about their family environment and familiarity with the various types of mobility aids. In addition, physical abilities will be measured at the start of the study, including measures of arm and leg strength, and the ability to walk and push a wheelchair. This will take about 30 minutes. A total of 150 subjects will be recruited among Veterans prescribed mobility aids in the preceding 3-12 months identified through administrative data sources.
The mobility aids being studied are all standard types of mobility aids used by people with limited mobility (e.g., wheeled walker, manual wheelchair, power wheelchair/scooter). Analyses will proceed in a stepwise fashion. The first step will be to examine the primary study question relating device type to the dependent variable, with velocity being the primary outcome. The next step in the analysis will be to determine if there is an interaction between medical condition, mobility devices, and the dependent variable. Finally, exploratory analyses will be carried out to examine the relationship between baseline measures of physical function and mobility performance with each of the devices. Study related risks are minimal.
- Conditions
- Chronic Heart Disorder, Lung Disorder, Arthritis
- Being tested
- Wheeled Mobility in Everyday Life:Effects of Wheelchair Type on Mobility Performance of Elders in Public Environments
- Keywords
- wheelchair, mobility disability, evidence based practice, self help devices, Veterans prescribed mobility aids
- Medical subject headings
- Lung Diseases, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheeled Mobility in Everyday Life:Effects of Wheelchair Type on Mobility Performance of Elders in Public EnvironmentsOther
Also called RERC-4a, Wheeled Mobility in Everyday Life
We are studying how wheeled mobility performance and the impact of device type on a group of community dwelling Veterans.
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed (in meters/second)
Measured: trial duration (generally 1 to 20 minutes)
Secondary outcomes (1)
Self Report of exertion, pain, fatigue,and device preference
Measured: completion of study (generally 20 to 40 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startOct 2008
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart DisorderStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen Hoenig, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981344
- Sponsor's protocol ID
- Pro00012299
- Other IDs
- NIDRR, H133E80003
- Acronym
- RERC-4a
- Status last verified
- Aug 2012
- First submitted
- 15 Sep 2009
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wheeled Mobility in Everyday Life: Effects of Wheelchair Type on Mobility Performance of Elders in Public Environments
- ClinicalTrials.gov ID
- NCT00981344
- Acronym / sponsor ID
- RERC-4a / Pro00012299
- Conditions
- Chronic Heart Disorder, Lung Disorder, Arthritis
- Keywords
- wheelchair, mobility disability, evidence based practice, self help devices, Veterans prescribed mobility aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project will examine how mobility performance in real life tasks and environments is impacted by the use of specific types of wheeled mobility devices (wheeled walker, manual wheelchair, power wheelchair/scooter). Specifically, the project will: 1) randomly recruit persons who were prescribed a mobility aid within the preceding 1 year and currently use the mobility aid, 2) define key mobility tasks within a public environment, 3) measure mobility performance of subjects as they perform the mobility tasks in each of the four devices, and 4) synthesize and disseminate the results. Study results will be used to establish baseline performance data for researchers and clinicians and to identify design improvements for wheelchairs used by community dwelling elders.
All study participants will be required to complete study related questionnaires about their family environment and familiarity with the various types of mobility aids. In addition, physical abilities will be measured at the start of the study, including measures of arm and leg strength, and the ability to walk and push a wheelchair. This will take about 30 minutes. A total of 150 subjects will be recruited among Veterans prescribed mobility aids in the preceding 3-12 months identified through administrative data sources.
The mobility aids being studied are all standard types of mobility aids used by people with limited mobility (e.g., wheeled walker, manual wheelchair, power wheelchair/scooter). Analyses will proceed in a stepwise fashion. The first step will be to examine the primary study question relating device type to the dependent variable, with velocity being the primary outcome. The next step in the analysis will be to determine if there is an interaction between medical condition, mobility devices, and the dependent variable. Finally, exploratory analyses will be carried out to examine the relationship between baseline measures of physical function and mobility performance with each of the devices. Study related risks are minimal.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Prescribed wheeled walker, manual wheelchair, power mobility device in last 3-12 months
- Have chronic heart (e.g., congestive heart failure) or lung disorder (e.g., chronic obstructive pulmonary disease), and/or arthritic disorder (e.g., osteoarthritis)
- Reports using wheeled walker, manual wheelchair, or power mobility device in the preceding 2 weeks
Key exclusion criteria (6 listed)
- Reports missing one or more limbs and/or complete paralysis of one or more limbs
- Have a neurological, myopathic, or cognitive disorder
- Weight more than 300 lbs; height more than 74 inches
- Poorly controlled hypertension, unstable angina, a heart attack or heart surgery within the last 6 months.
- Reports any of the following: Does not have an active Drivers License, unable to walk across small room without human help, unable to propel w/ch across small room without human help (applies only to those already using a manual w/ch), needs moderate assistance from another person to transfer, unable to sit on side of bed independently, currently has shoulder pain with self care or with wheelchair use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheeled Mobility in Everyday Life:Effects of Wheelchair Type on Mobility Performance of Elders in Public EnvironmentsAlso: RERC-4a, Wheeled Mobility in Everyday LifeWe are studying how wheeled mobility performance and the impact of device type on a group of community dwelling Veterans. | Other | – |
Primary outcome
Speed (in meters/second)
Time frame: trial duration (generally 1 to 20 minutes)
1 secondary outcome
Self Report of exertion, pain, fatigue,and device preference
Time frame: completion of study (generally 20 to 40 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Hoenig, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheeled Mobility in Everyday Life:Effects of Wheelchair Type on Mobility Performance of Elders in Public Environments in people with Chronic Heart Disorder and Lung Disorder, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed (in meters/second) (time frame: trial duration (generally 1 to 20 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2012.